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Medication adverse events

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https://www.readbyqxmd.com/read/29454051/retrospective-observational-study-of-the-use-of-artemether-lumefantrine-in-the-treatment-of-malaria-in-japan
#1
Fukumi Nakamura-Uchiyama, Yuichi Katanami, Tadashi Kikuchi, Saho Takaya, Satoshi Kutsuna, Taiichiro Kobayashi, Yasutaka Mizuno, Tetsuo Hasegawa, Michiko Koga, Yukihiro Yoshimura, Chihiro Hasegawa, Yasuyuki Kato, Mikio Kimura, Haruhiko Maruyama
BACKGROUND: The Research Group on Chemotherapy of Tropical Diseases, Japan, introduced artemether-lumefantrine (AL) in late 2002, mainly for treating uncomplicated Plasmodium falciparum malaria. Because AL was on the market in Japan in March 2017, the effectiveness and safety of AL were analyzed to help medical personnel use AL optimally. METHODS: Case report forms submitted by the attending physicians were analyzed. When necessary, direct contact with the attending physicians was made to obtain detailed information...
February 14, 2018: Travel Medicine and Infectious Disease
https://www.readbyqxmd.com/read/29453383/hyperbaric-oxygen-therapy-is-well-tolerated-and-effective-for-ulcerative-colitis-patients-hospitalized-for-moderate-severe-flares-a-phase-2a-pilot-multi-center-randomized-double-blind-sham-controlled-trial
#2
Parambir S Dulai, Jay C Buckey, Laura E Raffals, Jason M Swoger, Paul L Claus, Kevin O'Toole, Judy A Ptak, Michael W Gleeson, Christella E Widjaja, John T Chang, Jeffery M Adler, Nihal Patel, Laurie A Skinner, Shawn P Haren, Kimberly Goldby-Reffner, Kimberly D Thompson, Corey A Siegel
BACKGROUND: Hyperbaric oxygen therapy (HBOT) markedly increases tissue oxygen delivery. Case series suggest it may have a potential therapeutic benefit in ulcerative colitis (UC). We investigated the therapeutic potential of HBOT as an adjunct to steroids for UC flares requiring hospitalization. METHODS: The study was terminated early due to poor recruitment with 18 of the planned 70 patients enrolled. UC patients hospitalized for moderate-severe flares (Mayo score ≥6, endoscopic sub-score ≥2) were block randomized to steroids + daily HBOT (n = 10) or steroids + daily sham hyperbaric air (n = 8)...
February 16, 2018: American Journal of Gastroenterology
https://www.readbyqxmd.com/read/29452779/management-of-female-stress-urinary-incontinence-a-care-pathway-and-update
#3
REVIEW
Giampiero Capobianco, Massimo Madonia, Sonia Morelli, Francesco Dessole, Davide De Vita, Pier Luigi Cherchi, Salvatore Dessole
Stress urinary incontinence (SUI) is a condition characterized by an involuntary loss of urine occurring as result of an increase in intra-abdominal pressure due to effort or exertion or on sneezing or coughing. Estimates of its prevalence in the female population range from 10% to 40%. A literature search of the Medline, Cochrane library, EMBASE, NLH, ClinicalTrials.gov and Google Scholar databases was done up to July 2017, restricted to English-language articles, using terms related to SUI, medical therapy, surgical therapy and treatment options...
March 2018: Maturitas
https://www.readbyqxmd.com/read/29450893/dofetilide-for-suppression-of-atrial-fibrillation-in-hypertrophic-cardiomyopathy-a-case-series-and-literature-review
#4
JoEllyn C Moore, Lena Trager, Lucille E Anzia, Walid Saliba, Mohamed Bassiouny, Mandeep Bhargava, Mina Chung, Milind Desai, Ross Garberich, Harry Lever, Bruce D Lindsay, Jay Sengupta, Patrick Tchou, Oussama Wazni, Bruce L Wilkoff
BACKGROUND: Limited medical options are available for rhythm control in patients with atrial fibrillation (AF) and hypertrophic cardiomyopathy (HCM). There are no published reports of dofetilide use in this population. METHODS: A retrospective chart review was conducted on1,404 patients loaded on dofetilide for AF suppression at the Cleveland Clinic from 2008-2012, 25 of whom were found to have HCM. RESULTS: The HCM cohort was 32% female, 76% with persistent AF, mean age of 59 ± 10 years and mean ejection fraction (EF) of 54 ± 9 %...
February 16, 2018: Pacing and Clinical Electrophysiology: PACE
https://www.readbyqxmd.com/read/29450844/endobarrier%C3%A2-a-safe-and-effective-novel-treatment-for-obesity-and-type-2-diabetes
#5
Nisha Patel, Aruchuna Mohanaruban, Hutan Ashrafian, Carel Le Roux, James Byrne, John Mason, James Hopkins, Jamie Kelly, Julian Teare
BACKGROUND AND AIMS: Obesity associated with diabetes mellitus is a significant worldwide problem associated with considerable health care costs. Whilst surgical intervention is effective, it is invasive, costly and associated with complications. This study aims to evaluate the safety and efficacy of the EndoBarrier®, a duodenal-jejunal sleeve bypass as an alternative treatment of diabetes mellitus in obese patients. MATERIALS AND METHODS: This was a multi-centre, non-randomised trial recruiting obese patients with type 2 diabetes from three sites in the UK...
February 15, 2018: Obesity Surgery
https://www.readbyqxmd.com/read/29450684/application-and-impact-of-run-in-studies
#6
Michael Fralick, Jerry Avorn, Jessica M Franklin, Abdurrahman Abdurrob, Aaron S Kesselheim
BACKGROUND: A run-in phase is often employed prior to randomization in a clinical trial to exclude non-adherent patients, placebo responders, active drug non-responders, or patients who do not tolerate the active drug. This may impact the generalizability of trial results. OBJECTIVE: To determine if clinical outcomes differed between randomized controlled trials with run-in phases compared with randomized controlled trials of the same medication without run-in phases...
February 15, 2018: Journal of General Internal Medicine
https://www.readbyqxmd.com/read/29450524/effect-of-a-quality-improvement-intervention-on-clinical-outcomes-in-patients-in-india-with-acute-myocardial-infarction-the-acs-quik-randomized-clinical-trial
#7
Mark D Huffman, Padinhare P Mohanan, Raji Devarajan, Abigail S Baldridge, Dimple Kondal, Lihui Zhao, Mumtaj Ali, Mangalath N Krishnan, Syam Natesan, Rajesh Gopinath, Sunitha Viswanathan, Joseph Stigi, Johny Joseph, Somanathan Chozhakkat, Donald M Lloyd-Jones, Dorairaj Prabhakaran
Importance: Wide heterogeneity exists in acute myocardial infarction treatment and outcomes in India. Objective: To evaluate the effect of a locally adapted quality improvement tool kit on clinical outcomes and process measures in Kerala, a southern Indian state. Design, Setting, and Participants: Cluster randomized, stepped-wedge clinical trial conducted between November 10, 2014, and November 9, 2016, in 63 hospitals in Kerala, India, with a last date of follow-up of December 31, 2016...
February 13, 2018: JAMA: the Journal of the American Medical Association
https://www.readbyqxmd.com/read/29449951/glucagon-like-peptide-1-receptor-agonists-are-not-associated-with-retinal-adverse-events-in-the-fda-adverse-event-reporting-system
#8
Gian Paolo Fadini, Mayur Sarangdhar, Angelo Avogaro
Objectives: Glucagon-like peptide-1 receptor agonists (GLP-1RA) are widely used for the treatment of type 2 diabetes. In large trials, the GLP-1RAs liraglutide and semaglutide improved cardiovascular outcomes, but semaglutide was associated with an increased risk of retinopathy progression. We herein evaluated the association between GLP-1RA and retinal adverse events (AE) in the Food and Drug Administration Adverse Event Reporting System (FAERS). Research design and methods: We mined the FAERS between 2004q1 and 2017q1 (for a total of 9 217 555 AE reports) to analyze disproportionality and evaluate the association between GLP-1RAs and AEs involving the retina...
2018: BMJ Open Diabetes Research & Care
https://www.readbyqxmd.com/read/29449770/adverse-events-following-cervical-manipulative-therapy-consensus-on-classification-among-dutch-medical-specialists-manual-therapists-and-patients
#9
Hendrikus A Kranenburg, Sandra E Lakke, Maarten A Schmitt, Cees P Van der Schans
Objectives: To obtain consensus-based agreement on a classification system of adverse events (AE) following cervical spinal manipulation. The classification system should be comprised of clear definitions, include patients' and clinicians' perspectives, and have an acceptable number of categories. Methods: Design : A three-round Delphi study. Participants : Thirty Dutch participants (medical specialists, manual therapists, and patients) participated in an online survey...
December 2017: Journal of Manual & Manipulative Therapy
https://www.readbyqxmd.com/read/29449262/systematic-review-of-systematic-reviews-for-medical-cannabinoids-pain-nausea-and-vomiting-spasticity-and-harms
#10
G Michael Allan, Caitlin R Finley, Joey Ton, Danielle Perry, Jamil Ramji, Karyn Crawford, Adrienne J Lindblad, Christina Korownyk, Michael R Kolber
OBJECTIVE: To determine the effects of medical cannabinoids on pain, spasticity, and nausea and vomiting, and to identify adverse events. DATA SOURCES: MEDLINE, the Cochrane Database, and the references of included studies were searched. STUDY SELECTION: Systematic reviews with 2 or more randomized controlled trials (RCTs) that focused on medical cannabinoids for pain, spasticity, or nausea and vomiting were included. For adverse events, any meta-analysis for the conditions listed or of adverse events of cannabinoids was included...
February 2018: Canadian Family Physician Médecin de Famille Canadien
https://www.readbyqxmd.com/read/29449241/simplified-guideline-for-prescribing-medical-cannabinoids-in-primary-care
#11
G Michael Allan, Jamil Ramji, Danielle Perry, Joey Ton, Nathan P Beahm, Nicole Crisp, Beverly Dockrill, Ruth E Dubin, Ted Findlay, Jessica Kirkwood, Michael Fleming, Ken Makus, Xiaofu Zhu, Christina Korownyk, Michael R Kolber, James McCormack, Sharon Nickel, Guillermina Noël, Adrienne J Lindblad
OBJECTIVE: To develop a clinical practice guideline for a simplified approach to medical cannabinoid use in primary care; the focus was on primary care application, with a strong emphasis on best available evidence and a promotion of shared, informed decision making. METHODS: The Evidence Review Group performed a detailed systematic review of 4 clinical areas with the best evidence around cannabinoids: pain, nausea and vomiting, spasticity, and adverse events. Nine health professionals (2 generalist family physicians, 2 pain management-focused family physicians, 1 inner-city family physician, 1 neurologist, 1 oncologist, 1 nurse practitioner, and 1 pharmacist) and a patient representative comprised the Prescribing Guideline Committee (PGC), along with 2 nonvoting members (pharmacist project managers)...
February 2018: Canadian Family Physician Médecin de Famille Canadien
https://www.readbyqxmd.com/read/29449189/adjuvant-chemoradiotherapy-versus-radiotherapy-alone-for-women-with-high-risk-endometrial-cancer-portec-3-final-results-of-an-international-open-label-multicentre-randomised-phase-3-trial
#12
Stephanie M de Boer, Melanie E Powell, Linda Mileshkin, Dionyssios Katsaros, Paul Bessette, Christine Haie-Meder, Petronella B Ottevanger, Jonathan A Ledermann, Pearly Khaw, Alessandro Colombo, Anthony Fyles, Marie-Helene Baron, Ina M Jürgenliemk-Schulz, Henry C Kitchener, Hans W Nijman, Godfrey Wilson, Susan Brooks, Silvestro Carinelli, Diane Provencher, Chantal Hanzen, Ludy C H W Lutgens, Vincent T H B M Smit, Naveena Singh, Viet Do, Romerai D'Amico, Remi A Nout, Amanda Feeney, Karen W Verhoeven-Adema, Hein Putter, Carien L Creutzberg
BACKGROUND: Although women with endometrial cancer generally have a favourable prognosis, those with high-risk disease features are at increased risk of recurrence. The PORTEC-3 trial was initiated to investigate the benefit of adjuvant chemotherapy during and after radiotherapy (chemoradiotherapy) versus pelvic radiotherapy alone for women with high-risk endometrial cancer. METHODS: PORTEC-3 was an open-label, international, randomised, phase 3 trial involving 103 centres in six clinical trials collaborating in the Gynaecological Cancer Intergroup...
February 12, 2018: Lancet Oncology
https://www.readbyqxmd.com/read/29448967/facial-nerve-stimulation-in-normal-pigs-and-healthy-human-volunteers-transitional-development-of-a-medical-device-for-the-emergency-treatment-of-ischemic-stroke
#13
Olivia Sanchez, Andrea García, Fernando Castro-Prado, Miriam Perez, Rafael Lara-Estrada, Martin Ramirez-Meza, Montserrat Godinez, Michael L Coco, Joaquín Azpiroz, Mark K Borsody, Emilio Sacristán
BACKGROUND: Magnetic stimulation of the facial nerve has been tested in preclinical studies as a new, non-invasive emergency treatment of ischemic stroke that acts by increasing cerebral blood flow (CBF). The objective of the studies reported herein was to identify minimal stimulation parameters that increase CBF in large animals and then test those stimulation parameters in healthy volunteers for safety, tolerability, and effectiveness at increasing CBF. This translational research is necessary preparation for clinical studies in ischemic stroke patients...
February 15, 2018: Journal of Translational Medicine
https://www.readbyqxmd.com/read/29447887/thirty-day-perioperative-outcomes-in-resection-of-cervical-lymphatic-malformations
#14
Ashoke Khanwalkar, John Carter, Bharat Bhushan, Jeff Rastatter, John Maddalozzo
INTRODUCTION: Limited information exists regarding short-term morbidity in the resection of lymphatic malformations. In order to make informed collaborative medical decisions, clinicians and families would benefit from information on 30-day outcomes and the expected course associated with surgical excision of lymphatic malformations. METHODS: A retrospective chart review was conducted to develop a case series of patients who underwent resection of lymphatic malformation at a pediatric tertiary care center between June 1, 2007 and September 30, 2016...
March 2018: International Journal of Pediatric Otorhinolaryngology
https://www.readbyqxmd.com/read/29446185/chart-validation-of-inpatient-icd-9-cm-administrative-diagnosis-codes-for-acute-myocardial-infarction-ami-among-intravenous-immune-globulin-igiv-users-in-the-sentinel-distributed-database
#15
Eric M Ammann, Marin L Schweizer, Jennifer G Robinson, Jayasheel O Eschol, Rami Kafa, Saket Girotra, Scott K Winiecki, Candace C Fuller, Ryan M Carnahan, Charles E Leonard, Cole Haskins, Crystal Garcia, Elizabeth A Chrischilles
BACKGROUND: The Sentinel Distributed Database (SDD) is a large database of patient-level administrative health care records, primarily derived from insurance claims and electronic health records, and is sponsored by the US Food and Drug Administration for medical product safety evaluations. Acute myocardial infarction (AMI) is a common study endpoint for drug safety studies that rely on health records from the SDD and other administrative databases. PURPOSE: In this chart validation study, we report on the positive predictive value (PPV) of inpatient International Classification of Diseases, Ninth Revision, Clinical Modification AMI administrative diagnosis codes (410...
February 15, 2018: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/29446035/sorting-through-the-safety-data-haystack-using-machine-learning-to-identify-individual-case-safety-reports-in-social-digital-media
#16
Shaun Comfort, Sujan Perera, Zoe Hudson, Darren Dorrell, Shawman Meireis, Meenakshi Nagarajan, Cartic Ramakrishnan, Jennifer Fine
INTRODUCTION: There is increasing interest in social digital media (SDM) as a data source for pharmacovigilance activities; however, SDM is considered a low information content data source for safety data. Given that pharmacovigilance itself operates in a high-noise, lower-validity environment without objective 'gold standards' beyond process definitions, the introduction of large volumes of SDM into the pharmacovigilance workflow has the potential to exacerbate issues with limited manual resources to perform adverse event identification and processing...
February 14, 2018: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/29445962/impact-of-surgical-case-order-on-peri-operative-outcomes-for-total-joint-arthroplasty
#17
Xiang Li, Qi Zhang, Jiyuan Dong, Guoqiang Zhang, Wei Chai, Jiying Chen
INTRODUCTION: There is growing support in the literatures that peri-operative outcomes are adversely affected by surgical case order in some certain surgical procedures. This study aimed to examine if similar phenomenon is also shared in total joint arthroplasty (TJA). METHODS: A total of 6548 joints (5183 patients) treated with primary TJA by a total of five surgeons at our institution from December 2011 to December 2015 were retrospectively reviewed in this study...
February 14, 2018: International Orthopaedics
https://www.readbyqxmd.com/read/29445840/-serious-adverse-events-in-clinical-trials-with-tavr-and-savr
#18
U Barth
BACKGROUND: The expansion of the transcatheter aortic valve replacement (TAVR) indication towards patients with intermediate surgical risk (Ref. Society of Thoracic Surgeons, STS, score) was analyzed. The aim was to investigate if the complication rates particularly with respect to TAVR and surgical aortic valve replacement (SAVR) concerning patients with intermediate risk are comparable. METHODS: An analysis of serious adverse events (SAEs) and complication rates in clinical trials with TAVR and SAVR of these patients in comparison with high surgical risk patients was performed with the scientific literature and in the Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM) database (2012-2017)...
February 14, 2018: Herz
https://www.readbyqxmd.com/read/29445001/interventional-treatment-of-severe-tricuspid-regurgitation-early-clinical-experience-in-a-multicenter-observational-first-in-man-study
#19
Alexander Lauten, Hans R Figulla, Axel Unbehaun, Neil Fam, Joachim Schofer, Torsten Doenst, Joerg Hausleiter, Marcus Franz, Christian Jung, Henryk Dreger, David Leistner, Brunilda Alushi, Anja Stundl, Ulf Landmesser, Volkmar Falk, Karl Stangl, Michael Laule
BACKGROUND: Transcatheter caval valve implantation is under evaluation as a treatment option for inoperable patients with severe tricuspid regurgitation (TR). The procedure involves the catheter-based implantation of bioprosthetic valves in the inferior vena cava and superior vena cava to treat symptoms associated with TR. This study is the first to evaluate the feasibility, safety, and efficacy of this interventional concept. METHODS AND RESULTS: Twenty-five patients (mean age, 73...
February 2018: Circulation. Cardiovascular Interventions
https://www.readbyqxmd.com/read/29444778/efficacy-and-safety-of-the-shexiang-baoxin-pill-for-the-treatment-of-coronary-artery-disease-not-amenable-to-revascularisation-study-protocol-for-a-randomised-placebo-controlled-double-blinded-trial
#20
Pan-Pan Tian, Jun Li, Jian Gao, Ying Li
INTRODUCTION: Coronary artery disease (CAD) not amenable to revascularisation indicates that the coronary arteries have severe diffuse lesions or calcifications, or that CAD is complicated with severe multiple-organ disease. Currently, Western medicines available for the treatment of CAD not amenable to revascularisation are limited. Shexiang Baoxin Pill (SBP), a type of Chinese patent medicine, has been widely used to treat CAD in China for many years. Previous studies have shown that long-term administration of SBP (1-2 pills three times daily, for at least 6 months) for treatment of CAD is effective and safe, with a significant, long-term effect...
February 14, 2018: BMJ Open
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